Deskripsi Pekerjaan
Are you a highly motivated Quality Assurance professional with a passion for ensuring product excellence from inception to market? GSK, a global leader in healthcare and pharmaceuticals, is seeking a dedicated Senior Quality Assurance Executive to join our dynamic team in Tuas, Singapore. This pivotal role will place you at the forefront of our innovation pipeline, supporting and leading critical validation activities for new product introductions (NPI) and product transfers.
At GSK, we are committed to improving human health through groundbreaking science and the delivery of high-quality products. As a Senior QA Executive, you will play a crucial part in upholding this commitment by rigorously applying GxP principles and regulatory standards to all phases of product lifecycle. You will collaborate closely with cross-functional teams including R&D, Manufacturing, Engineering, and Regulatory Affairs, ensuring that all processes, equipment, and products meet the highest quality and safety benchmarks.
This is an exceptional opportunity for a proactive individual who thrives in a fast-paced, highly regulated environment. If you possess a keen eye for detail, strong problem-solving abilities, and a proven track record in pharmaceutical QA, we invite you to contribute to a purpose-driven organization that values innovation, integrity, and patient impact. Join GSK and help us deliver life-changing medicines and vaccines to patients worldwide.
Tanggung Jawab
- Lead and support the development and execution of validation protocols (e.g., DQ, IQ, OQ, PQ) for new products, processes, equipment, and facilities during NPI and product transfer projects.
- Ensure all validation activities and documentation comply with cGMP, regulatory requirements (e.g., HSA, FDA, EMA), and internal GSK Quality Management System (QMS) standards.
- Review and approve manufacturing batch records, deviations, CAPAs, change controls, and other quality-related documentation to ensure product quality and integrity.
- Collaborate with R&D, Manufacturing, Engineering, and Supply Chain teams to integrate quality by design principles into new product development and technology transfer initiatives.
- Participate in risk assessments and investigations of quality incidents, identifying root causes and implementing effective corrective and preventive actions.
- Provide expert QA guidance and support to project teams for NPI and product transfer, ensuring a smooth transition from development to commercial production.
- Conduct periodic internal audits and support external regulatory inspections, ensuring continuous readiness and compliance.
- Drive continuous improvement initiatives within the Quality Assurance function and across relevant operational areas.
Kualifikasi
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related scientific discipline.
- Minimum of 3-5 years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Demonstrated experience in New Product Introduction (NPI), product transfer, and leading validation activities (DQ, IQ, OQ, PQ).
- Strong knowledge and practical application of GxP (GMP, GLP, GDP), ISO standards, and relevant international regulatory requirements.
- Excellent analytical, problem-solving, and decision-making skills with a meticulous attention to detail.
- Ability to work effectively in a cross-functional team environment and influence stakeholders at various levels.
- Proficiency in written and spoken English, with strong technical writing and communication abilities.
- Experience with Quality Management Systems (QMS) and electronic document management systems is preferred.